The Effect of Bedside Ultrasound Assistance on the Proportion of Successful Infant Lumbar Punctures in a Pediatric Emergency Department: A Randomized Controlled Trial
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Traumatic Lumbar Puncture
- Sponsor
- Children's Hospital of Philadelphia
- Enrollment
- 128
- Locations
- 1
- Primary Endpoint
- Percentage of Successful First Attempt Lumbar Punctures in the Ultrasound-assisted Group as Compared to the Non-ultrasound Assisted Group
- Status
- Completed
- Last Updated
- 8 years ago
Overview
Brief Summary
The reported rate of unsuccessful spinal taps in children, especially young infants, is high. Our hypothesis is that ultrasound assistance can improve the success rate of spinal taps.
Detailed Description
The reported rate of unsuccessful spinal taps in children is high. At the Children's Hospital of Philadelphia (CHOP), quality improvement data demonstrates a failure rate of \~40-50%. Research has shown that bedside ultrasound can improve visualization and improve the success rate of spinal taps. Increasing the proportion of successful spinal taps in the emergency department could significantly reduce the rate of unnecessary hospitalizations, additional interventional procedures and antibiotic use. Our objective is to determine if bedside ultrasound-assisted site marking will increase the proportion of first attempt successful spinal taps. This will be a prospective, randomized controlled study that will take place over the course of 18 months with the goal to recruit a sample of approximately 128 patients. We will recruit subjects from the CHOP Emergency Department. The patients will be randomized into an ultrasound-assisted group versus a non-ultrasound-assisted group. Our hypothesis is that bedside ultrasound-assisted site marking will increase the number of successful spinal taps.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Less than or equal to six months of age
- •Plan for diagnostic or therapeutic lumbar puncture as per front line clinician
- •Availability of a study sonographer to perform bedside ultrasound
Exclusion Criteria
- •Known spinal cord abnormality (e.g., tethered cord, spina bifida)
Outcomes
Primary Outcomes
Percentage of Successful First Attempt Lumbar Punctures in the Ultrasound-assisted Group as Compared to the Non-ultrasound Assisted Group
Time Frame: 30 minutes
First attempt success in ultrasound-assisted group compared to first attempt success in non-ultrasound assisted group
Secondary Outcomes
- Percentage of Overall Success of Lumbar Punctures in the Ultrasound-assisted Group Versus the Non-ultrasound-assisted Group(30 minutes)
- Length of Hospitalization in Ultrasound-assisted Lumbar Puncture Patients Versus Non-ultrasound-assisted Patients(Participants will be followed for the duration of the hospital stay, an expected average of 2 days)
- Length of Antibiotic Use in Ultrasound-assisted Lumbar Puncture Patients Versus Non-ultrasound-assisted Patients(Participants will be followed until discontinuation of antibiotics, an expected average of 2 days)